FDA.report

Application 075757

Type
ANDA
Sponsor
SANDOZ

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL10MGNoNo
002OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL20MGNoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1359OmeprazoleOmeprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7933OmeprazoleOmeprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7933OmeprazoleOmeprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8320OmeprazoleOmeprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8320OmeprazoleOmeprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8320OmeprazoleOmeprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-2785OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2785OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2785OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2785OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2790OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2790OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2790OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2790OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2859OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2859OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2859OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2859OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2868OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2868OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2868OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2868OmeprazoleOmeprazoleSandoz IncANDACurrent
50090-2901OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
60760-868OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-868OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-868OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-868OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-868OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
67046-700OmeprazoleOmeprazoleContract Pharmacy Services-PAANDACurrent
68071-2655OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
70518-0905OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-0905OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-1019OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-1019OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-2295OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-2295OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-2295OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-2295OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-2295OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70934-335OmeprazoleOmeprazoleDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-335OmeprazoleOmeprazoleDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-335OmeprazoleOmeprazoleDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0559OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
71335-0559OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
71335-0559OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
71335-0559OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
71335-9609OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent